Status:
COMPLETED
The Akloma Tinnitus Patch in Patients With Manifested Tinnitus
Lead Sponsor:
Akloma Bioscience AB
Conditions:
Tinnitus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
OBJECTIVES: Primary Objective The primary objective will be a decrease of inconvenience with at least 10% for at least 50% of the subjects. Secondary Objectives The secondary objective will be to: ...
Eligibility Criteria
Inclusion
- Adults of both sexes \> 18 years of age
- Signed informed consent
- Patients who have suffered from tinnitus for ≥ 4 weeks before study entry
- Manifested tinnitus grade II or above on the Klockhoff-Lindblom tinnitus severity grading scale.
- Tinnitus score of 5 or above (numerical rating scale for tinnitus annoyance)
- Pure tone averages better than 40 dB in the worse hearing ear.
Exclusion
- Pregnant or lactating women
- Malignancy or other serious medical conditions
- Skin disease
- Simultaneous or previous (within 30 days prior to study entry) participation in a clinical study using experimental drugs or devices.
- Severe psychiatric disorder
- Serious suicidal risk
- Patients who have started treatment or made changes in treatment with drugs known to influence tinnitus within 6 weeks before study start.
- Patients with untreated high blood pressure ≥140/90 mmHg
- Other tinnitus treatment within 6 weeks before study entry.
- Previous use of the Antinitus patch
- Known allergy or sensitivity to any of the compounds in the Antinitus or the placebo patches.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01226108
Start Date
October 1 2010
Last Update
September 26 2011
Active Locations (1)
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1
Sickla ÖNH-center, Atlashuset Planiavägen 5
Nacka, Sweden, 131 34